{"id":2891,"date":"2026-10-01T14:27:01","date_gmt":"2026-10-01T14:27:01","guid":{"rendered":"https:\/\/jxl-069.com\/?p=2891"},"modified":"2026-10-01T14:27:01","modified_gmt":"2026-10-01T14:27:01","slug":"pp405-explained-pelage-clinical-trials","status":"publish","type":"post","link":"https:\/\/jxl-069.com\/es\/pp405-explained-pelage-clinical-trials\/","title":{"rendered":"PP405 explicado: ensayos cl\u00ednicos de Pelage y estado 2026"},"content":{"rendered":"<p class=\"translation-block\"><strong>Solo para investigaci\u00f3n.<\/strong> Este art\u00edculo resume informaci\u00f3n p\u00fablica sobre PP405, un producto en investigaci\u00f3n de Pelage Pharmaceuticals. PP405 no est\u00e1 aprobado en ning\u00fan pa\u00eds. JXL-069, que se vende en este sitio para investigaci\u00f3n de laboratorio, es un compuesto de investigaci\u00f3n distinto: no est\u00e1 aprobado, no tiene datos de seguridad en humanos y los resultados de los ensayos de PP405 no se aplican a \u00e9l.<\/p>\n<h2>\u00bfQu\u00e9 es PP405?<\/h2>\n<p>PP405 es una mol\u00e9cula peque\u00f1a de uso t\u00f3pico desarrollada por Pelage Pharmaceuticals, una empresa fundada a partir de investigaci\u00f3n de UCLA. Pelage la describe como una mol\u00e9cula peque\u00f1a t\u00f3pica y no invasiva dise\u00f1ada para reactivar las c\u00e9lulas madre del fol\u00edculo piloso en reposo. Su mecanismo es la inhibici\u00f3n del transportador mitocondrial de piruvato (MPC). Pelage no ha publicado la estructura qu\u00edmica de PP405.<\/p>\n<h2>\u00bfQui\u00e9n est\u00e1 detr\u00e1s de PP405?<\/h2>\n<p>Pelage fue fundada por los cient\u00edficos de UCLA William Lowry, Heather Christofk y Michael Jung, cuyos laboratorios publicaron la investigaci\u00f3n en ratones sobre el lactato y las c\u00e9lulas madre del fol\u00edculo piloso (Flores et al., 2017) y la serie de inhibidores del MPC que incluye JXL069 (Liu et al., 2021). Seg\u00fan Pelage, la propiedad intelectual de PP405 y de mol\u00e9culas t\u00f3picas relacionadas se licenci\u00f3 de UCLA en 2018.<\/p>\n<p>Pelage ha anunciado tres rondas de financiaci\u00f3n: una Serie A de 16,75 millones de d\u00f3lares liderada por GV en febrero de 2024, una Serie A-1 de 14 millones de d\u00f3lares liderada por GV en agosto de 2024 y una Serie B de 120 millones de d\u00f3lares codirigida por ARCH Venture Partners y GV en octubre de 2025.<\/p>\n<h2>Fase 1b y primeros datos en humanos<\/h2>\n<p>En marzo de 2024, Pelage present\u00f3 datos de \u00faltima hora en el congreso de la Academia Americana de Dermatolog\u00eda. Seg\u00fan la empresa, su estudio de fase 1b en personas con alopecia androgen\u00e9tica mostr\u00f3 que PP405 al 0,05% aplicado a diario en el cuero cabelludo se toleraba bien sin niveles detectables del f\u00e1rmaco en sangre, y que a los siete d\u00edas las biopsias mostraban un aumento significativo del marcador de proliferaci\u00f3n Ki67 respecto al valor inicial. En tejido de cuero cabelludo humano estudiado ex vivo, PP405 aument\u00f3 la actividad de la lactato deshidrogenasa en las c\u00e9lulas madre del fol\u00edculo en 24 horas. Son resultados comunicados por la empresa, no una publicaci\u00f3n revisada por pares.<\/p>\n<h2>Resultados del ensayo de fase 2a<\/h2>\n<p>El ensayo de fase 2a (ClinicalTrials.gov NCT06393452) fue aleatorizado, doble ciego y controlado con veh\u00edculo. Incluy\u00f3 a 78 hombres y mujeres de 18 a 55 a\u00f1os con alopecia androgen\u00e9tica. Los participantes se aplicaron en el cuero cabelludo gel de PP405 al 0,05% o un gel placebo una vez al d\u00eda durante 4 semanas y se les hizo seguimiento hasta la semana 12.<\/p>\n<ul>\n<li>Seguridad: seg\u00fan Pelage, el ensayo cumpli\u00f3 su criterio principal de seguridad y su criterio farmacocin\u00e9tico. PP405 se toler\u00f3 bien y no se detect\u00f3 absorci\u00f3n sist\u00e9mica en sangre.<\/li>\n<li>Eficacia: Pelage comunic\u00f3 que en la semana 8, cuatro semanas despu\u00e9s de terminar el tratamiento, el 31% de los hombres con mayor grado de ca\u00edda del cabello tratados con PP405 mostr\u00f3 un aumento de la densidad capilar superior al 20%, frente al 0% del grupo placebo.<\/li>\n<li>Esa cifra de eficacia procede de un subgrupo, se anunci\u00f3 en un comunicado de prensa de la empresa en junio de 2025 y no se ha publicado en una revista revisada por pares.<\/li>\n<li>Los resultados publicados en ClinicalTrials.gov en septiembre de 2026 cubren seguridad y farmacocin\u00e9tica. No se registraron acontecimientos adversos graves en el grupo de PP405 (hubo uno en el grupo placebo), y los efectos secundarios m\u00e1s frecuentes fueron picor y enrojecimiento en la zona de aplicaci\u00f3n.<\/li>\n<\/ul>\n<h2>Lo que viene: el ensayo AWAKEN<\/h2>\n<p>Pelage indic\u00f3 que esperaba iniciar estudios de fase 3 en 2026. En septiembre de 2026 se registr\u00f3 en ClinicalTrials.gov un ensayo de fase 2\/3 llamado AWAKEN (NCT07819435). Prev\u00e9 incluir a unos 600 hombres de 18 a 55 a\u00f1os con alopecia androgen\u00e9tica, compara el gel de PP405 al 0,05% con un gel veh\u00edculo y utiliza como criterio principal el cambio en el recuento de pelos no vellosos en una zona diana. En el momento del registro a\u00fan no reclutaba, con una fecha estimada de finalizaci\u00f3n primaria en diciembre de 2027.<\/p>\n<h2>Lo que PP405 a\u00fan no ha demostrado<\/h2>\n<ul>\n<li>No se han publicado datos de eficacia en humanos revisados por pares.<\/li>\n<li>No se ha comunicado la seguridad a largo plazo; AWAKEN est\u00e1 dise\u00f1ado para estudiarla.<\/li>\n<li>La cifra de eficacia de la fase 2a se refiere a un subgrupo de hombres y a un periodo de tratamiento corto.<\/li>\n<li>PP405 no est\u00e1 aprobado y no est\u00e1 disponible como medicamento.<\/li>\n<\/ul>\n<h2>Relaci\u00f3n entre PP405 y JXL-069<\/h2>\n<p class=\"translation-block\">Ambos proceden de la misma investigaci\u00f3n de UCLA sobre el MPC. En 2026 la OMS propuso el nombre suvomipic para un inhibidor del MPC con exactamente la estructura publicada para JXL069, pero Pelage no ha vinculado oficialmente PP405 con ese nombre ni con ninguna estructura. Lo explicamos en detalle en <a href=\"https:\/\/jxl-069.com\/es\/jxl-069-vs-other-experimental-compounds-a-lab-focused-comparison\/\">JXL-069 vs PP405<\/a> y <a href=\"https:\/\/jxl-069.com\/es\/what-is-jxl-069-pp405-a-researchers-primer\/\">\u00bfQu\u00e9 es JXL-069?<\/a>.<\/p>\n<p class=\"translation-block\">Para trabajo de laboratorio sobre inhibici\u00f3n del MPC: <a href=\"https:\/\/jxl-069.com\/es\/product\/jxl-069-pp405-research-serum\/\">JXL-069 (compuesto de comparaci\u00f3n con PP405) al 0,05% p\/v de 30 mL<\/a> y <a href=\"https:\/\/jxl-069.com\/es\/product\/jxl-069-raw-powder\/\">JXL-069 en polvo<\/a>, solo para uso en investigaci\u00f3n.<\/p>\n<h2>Referencias<\/h2>\n<ol>\n<li class=\"translation-block\">Pelage Pharmaceuticals. Pelage Pharmaceuticals Announces Positive Phase 2a Clinical Trial Results for PP405 in Regenerative Hair Loss Therapy. Comunicado de prensa, 17 de junio de 2025. <a href=\"https:\/\/pelagepharma.com\/press-releases\/pelage-pharmaceuticals-announces-positive-phase-2a-clinical-trial-results-for-pp405-in-regenerative-hair-loss-therapy\/\" rel=\"nofollow noopener\" target=\"_blank\">pelagepharma.com<\/a><\/li>\n<li class=\"translation-block\">Pelage Pharmaceuticals. Pelage Presents Late-Breaking Data at AAD 2024 Meeting. Comunicado de prensa, 9 de marzo de 2024. <a href=\"https:\/\/pelagepharma.com\/press-releases\/pelage-presents-late-breaking-data-at-aad-2024-meeting-demonstrating-pp405-activates-human-hair-follicle-stem-cells-ex-vivo-and-in-phase-1-clinical-study\/\" rel=\"nofollow noopener\" target=\"_blank\">pelagepharma.com<\/a><\/li>\n<li class=\"translation-block\">Pelage Pharmaceuticals. Comunicados sobre financiaci\u00f3n: 27 de febrero de 2024, 13 de agosto de 2024 y 15 de octubre de 2025. <a href=\"https:\/\/pelagepharma.com\/press-releases\/\" rel=\"nofollow noopener\" target=\"_blank\">pelagepharma.com\/press-releases<\/a><\/li>\n<li class=\"translation-block\">ClinicalTrials.gov. NCT06393452: Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA (fase 2a). <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06393452\" rel=\"nofollow noopener\" target=\"_blank\">clinicaltrials.gov<\/a><\/li>\n<li class=\"translation-block\">ClinicalTrials.gov. NCT07819435: Phase 2\/3 Efficacy and Safety of PP405 in Adult Males (AWAKEN). <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT07819435\" rel=\"nofollow noopener\" target=\"_blank\">clinicaltrials.gov<\/a><\/li>\n<li class=\"translation-block\">Flores A, Schell J, Krall AS, et al. Lactate dehydrogenase activity drives hair follicle stem cell activation. Nat Cell Biol. 2017;19(9):1017-1026. <a href=\"https:\/\/doi.org\/10.1038\/ncb3575\" rel=\"nofollow noopener\" target=\"_blank\">doi:10.1038\/ncb3575<\/a><\/li>\n<li class=\"translation-block\">Liu X, Flores AA, Situ L, et al. Development of Novel Mitochondrial Pyruvate Carrier Inhibitors to Treat Hair Loss. J Med Chem. 2021;64(4):2046-2063. <a href=\"https:\/\/doi.org\/10.1021\/acs.jmedchem.0c01570\" rel=\"nofollow noopener\" target=\"_blank\">doi:10.1021\/acs.jmedchem.0c01570<\/a><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Research use only. This article summarises public information about PP405, an investigational product of Pelage Pharmaceuticals. PP405 is not approved anywhere. JXL-069, sold on this site for laboratory research, is a separate research compound: it is not approved and has no human safety data, and PP405 trial results do not apply to it. What is [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2891","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>PP405 Explained: Pelage Clinical Trials &amp; 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